- Email: [email protected]
The acceptability of medical abortion and other uses of mifepristone
Anna Glasier For the great majority of women the decision to have a pregnancy terminated is a difficult and painful one. The circumstances surrounding the need for abortion, such as the end of a relationship, are often distressing. Many women feel guilty about destroying the fetus and most are fearful about the abortion procedure. Since the deveiopment of a medical method for inducing abortion - mifepn’stone (first known as RU486)pJus prostaglandin -in countries where the two drugs are licensed and in settings where medical techniques are available, women are being given a choice as to how they would prefer theirpregnancy to be terminated. The freedom to choose the method of abortion may help to alleviate some of their anxiety and it is interesting to review why women choose one method rather than another. This paper reviews existing studies and discusses the potential limitations on the development ofmifepn’stone for contraceptive use, for emergency contraception and other possible indications because of anti-abortion pressure.
HE acceptability of medical abortion using mifepristone has been assessed in a number of cultural settings - Scotland,1,2,3 England,4 Sweden,5 France,” Denrnark,7 Hong Kong,*tg and the USA.l” The studies differ quite significantly, however, and are difficult to compare. Most were undertaken when RU486 was new and at a time when RU486 was unlicensed in the particular country where the study was done. Many women are understandably hesitant to opt for a new and relatively untested treatment in whatever field of medicine, and this almost certainly affects not only which method they choose but also colours their experience of it. Many of the studies were undertaken as part of a trial of the efficacy of the method. In the Oxford study,4 for example, women were invited either to participate in the study or to undergo routine surgical abortion. They were not simply choosing between two methods, but also whether to participate in a trial or not. Where an acceptability study is tacked on to an efficacy study, the demands of the study itself undoubtedly influence the woman’s choice of method too. In Tang’s pilot study,8 for example, women choosing medical abortion had to attend the study site on seven separate occasions while those choosing surgical abortion had to attend Only twice.
T
Comparability of the studies is also complicated by significant differences in the details of the abortion method. Surgical abortion may be done under local or general anaesthetic, while medical abortion may involve the use of prostaglandins administered vaginally rather than intramuscularly. One of the studies7 used mifepristone alone. The duration of hospital stay also varied considerably. In one Scottish study,* the women were asked to stay in hospital for only four hours on the day of prostaglandin administration, compared with six hours in Hong Kong.* Again, in the Hong Kong centre8 surgical abortion involved an overnight stay in hospital which was not required in Scotland.3 Despite these major differences there are nevertheless enough similarities to allow some general comments about the acceptability of medical abortion with RU486. Most studies determined the reasons why women chose either medical or surgical abortion, whether women who chose one or other method had certain characteristics in common, and tried to make some standard assessment of acceptability by would which method a woman asking recommend to a friend or opt for in the future should the need arise. Perhaps the commonest reason why women
I 147 I
have chosen medical abortion as opposed to vacuum aspiration is the perception that the former is a more ‘natural’ procedure, which avoids exposure to general anaesthesia. In Hong Kong8 some women felt less guilty about having an abortion because the medical method seemed more like a natural miscarriage. The fear of general anaesthesia is obviously not an issue if surgical abortion is performed under local anaesthesia. In the French study’s only nine per cent of women chose vacuum aspiration under general anaesthesia while 27 per cent chose vacuum aspiration under local anaesthesia. Even when local anaesthesia was available, however, the great majority of women (62 per cent) opted for medical abortion. A minority of women, on the other hand, chose surgical abortion in the Hong Kong studf because they wanted to be unconscious and unaware of events. For some women the anxiety associated with ‘seeing the baby’ prompted a choice of general anaesthesia. In fact, this is not the case during first trimester medical abortion, when only blood and tissue are visible, so this fear is unfounded, a point which can be made during counselling. In most studies, some women’s choice of method has depended on their perception of its safety. Perceptions have varied considerably, with some women concerned about the safety of the drugs used for medical abortion and others concerned about the use of instruments for surgical abortion. As medical abortion becomes more widespread, the fear of the drugs will most likely decrease for many women. Medical abortion currently requires more visits to the hospital or clinic and a 48-hour wait between the two parts of the procedure. Many women have chosen surgical abortion because it appears to be quicker and to demand less time off work, unless an overnight stay is required, which is still the case in some countries. Moreover, the 48-hour wait inherent in medical abortion is a time of anxiety which some women feel unable to cope with. For some women the fear of side effects has deterred them from choosing medical abortion. In the multicentre study undertaken in the United Kingdom, l1 21 per cent of women complained of severe pain in the two days following prostaglandin administration and around 30 per cent of all participants required non-narcotic analgesia.
In addition, between 13 and 37 per cent needed narcotic analgesia, but this depended both on parity and also highly significantly on the centre where the abortion took place. Twenty-five per cent of the women vomited and 13 per cent experienced diarrhoea after prostaglandins were given. Thong and colleagues’ working in Edinburgh found that the need for analgesia was related to length of gestation, parity and a history of dysmenorrhoea - all factors which can be determined during the time of counselling a woman about her choice of method. Medical abortion is thought to involve more blood loss post-operatively and a longer duration of bleeding than with surgical abortion. In fact, the total blood loss is not greater. However, with a surgical procedure much of the bleeding occurs acutely at the time of operation and is unnoticed by the woman. In most studies, medical abortion seemed more likely to be chosen by women who were younger, single, better educated and of a higher socio-economic status. In an as yet unpublished audit from EdinburghI women who smoked were more likely to choose surgical abortion. In all the published studies, the vast majority of women were happy with whichever method they had chosen, said they would choose the same procedure again if the need for abortion arose, and would recommend it to a friend. It is difficult for a woman to choose between two methods unless she has experienced both and is faced with a choice on a third occasion. Even then, the circumstances surrounding the unplanned pregnancy and the professional staff involved with counselling and carrying out the abortion will almost certainly be different, and both will have a major influence on a woman’s feelings about the procedure. Perhaps the most helpful study of acceptability comes from Aberdeen3 in which the 54 per cent of women who felt unable to choose between the two procedures were randomised. As with other studies, around 90 per cent of the women who made a choice were happy with the outcome, but there were significant differences in the extent of dissatisfaction among those who were randomised. Only two per cent of randomised women were unhappy with surgical abortion, but 22 per cent were unhappy with the medical method. In contrast, in another study
Reproductive
from Aberdeen,l ten out of 13 women who had experienced both surgical and medical abortion said that they preferred medical abortion. This study is the only one which reported psychiatric morbidity associated with abortion, but it found no difference between medical and surgical methods. Given the choice between surgical and medical methods of inducing abortion, many women seem to prefer the medical approach. Whatever method they choose, a small minority of women find the experience unsatisfactory and it is possible that this is more likely when medical abortion is chosen. When any new therapy is introduced - particularly with the amount of publicity that surrounded RU486 abortion expectations may be unrealistically high. The provision of accurate and detailed information about all abortion procedures should overcome this problem. Indeed, the very fact that women themselves have a say in how the abortion is performed probably increases the acceptability of the method they choose.
OTHER USESOFMIFEPRISTONE RU486 has great potential for
use as a contraceptive method and a number of approaches - very low dose daily administration, once-a-week pills, once-a-month pills, and emergency post-coital contraception - are all being investigated. To date, researchers have concentrated on the efficacy of these methods rather than acceptability. Protocols for the development of new contraceptive techniques are complicated and entail a multitude of frequent and often invasive investigations, such as blood tests, cervical smears and endometrial biopsies, which are not necessary when the method becomes available for routine use. Moreover, phase 1 studies are often undertaken on women who are not at risk of pregnancy, women who are sterilised or using a barrier method of contraception, so true acceptability is almost impossible to measure. We undertook a surveyla of women in Scotland, Slovenia and Romania to determine the theoretical acceptability of a once-a-month pill. The once-a-month concept was acceptable, but in Scotland, and to a lesser extent in Slovenia, the acceptability depended on the mode of action. Only 24 per cent of the women in
Health Matters, No 6,
November
1995
Edinburgh were prepared to use a pill which acted after implantation had occurred and only 33 per cent in Slovenia. In two studies of 600 mg RU486 as an emergency post-coital contraceptive14,15 the incidence of side effects was highly significantly less in women who took RU486 in comparison with those given the standard combined oestrogen-progestogen (Yuzpe) regimen. Moreover, the Yuzpe regimen requires the ingestion of two doses of pills separated by 12 hours, while RU486 needs to be taken only once. Although this was not specifically measured, it is likely that the single dose and reduced side effects with RU486 given in this manner would make it more acceptable than the Yuzpe regimen. RU486 has great potential for development as a contraceptive and indeed, for other uses such as the treatment of breast cancer. Yet the use of RU486 and any other anti-progestin that may be developed will be limited if it is only thought of as an ‘abortion pill’. Thus, the introduction of an anti-progestin, for whatever other therapeutic use, into a country where abortion is illegal or where RU486 has not been licensed as an abortifacient may be extremely difficult. Even in countries where RU486 is licensed for the induction of early abortion, it is currently subject to more controls than perhaps any other drug. In the United Kingdom, for example, both the drug licensing authority and the manufacturers are responsible for a set of stringent restrictions on its provision. In some countries, such as the USA, drug regulatory authorities have a legal mandate to consider a product application only for the therapeutic purposes for which approval is sought. Nevertheless, ideological pressure, which may even come from the government itself, may be hard to resist. A review of the science and politics of RU486 in 1989 in the USA says: ‘. . As long as the deadlock on RU486 continues, its other potential lifesaving applications will remain unexplored.‘16 This review points out the fear that the licensing of the drug for one purpose would inevitably lead to it ultimately being used for abortion as well. This would almost certainly be the case in other countries. In the United
Glasier
Kingdom, once a drug becomes available a is free to use it as he or she sees fit. If the use accords with accepted clinical practice, legal redress is unlikely. Thus, many doctors prescribe oral contraceptive pills containing 50 mcg oestrogen for emergency contraception, even though the pills are not licensed for this purpose. Because the practice is so widespread and clinically sound, it is acceptable medico-legally. In this way, if RU486 were licensed for the treatment of breast cancer in a country where it was not licensed for abortion, a doctor could successfully argue for the validity of its use as an abortifacient, demonstrated in evidence from other countries. Even if doctors themselves refrained from providing RU486 for the unlicensed purpose of abortion, once it was available for other purposes and if it were available over the counter, there would be potential for its use doctor
directly by women as an abortifacient, as has happened with the anti-ulcer drug misoprostol (a prostaglandin) in Brazil and elsewhere, for inducing abortion illegally.17 If contraceptives containing an anti-progestin could only be administered in a controlled in the way that mifepristone is manner, administered today for early abortion, then it would not be possible to develop anti-progestins for contraception. Hence, either we have to accept that anti-abortion pressure may prevent the development or licensing of a range of therapeutic uses for mifepristone, even where it would be the preferred treatment, as seems to be the case with its use for emergency contraception, or we have to find a way to overcome the reluctance to license mifepristone for all of the scientifically proven indications it may have, starting with early abortion.
References 1. Urquhart D R and Templeton A A, 1991. Psychiatric morbidity and acceptability following medical and surgical methods of induced abortion. British Journal of Obstetrics and Gynaecology. 98:396-99. 2. Thong K J, Dewar M H and Baird D T, 1992. What do women want during medical abortion? Contraception. 46:435-42. 3. Henshaw R C, Naji S A, Russell I T et al, 1993. Comparison of medical abortion with surgical vacuum aspiration: women’s preferences and acceptability of treatment. British Medical Journal. 307:714-17. 4. Hill N C W, Ferguson J and Mackenzie I Z, 1990. The efficacy of oral mifepristone (RU38486) with aprostaglandin El analog vaginal pessary for the termination of early pregnancy : complications and patient acceptability. American Journal of Obstetrics and Gynecology. 162:414-17. 5. Holmgren K, 1992. Women’s evaluation of three early abortion methods. Acta Obstetrica Gynecologica
Scandinavia. 71:611-23. Bachelot A, Cludy Land Spira A, 1992. Conditions for choosing between drug-induced and surgical abortions. Contraception. 45:547-59. 7. Legarth J, Peen U B and Michelson J W, 1991. Mifepristone or vacuum aspiration in termination of early pregnancy. European Journal of Obstetrics, Gynecology and Reproductive Biology. 41:91-96. 8. Tang G W K, 1991. A pilot study of acceptability of RU486 and ON0802 in a Chinese population. Contraception. 44:523-32. 9 Tang G W K, Lau 0 W K and Yip P, 1993. Further acceptability evaluation of RU486 and ON0 802 as abortifacient agents in a Chinese population. Contraception. 48267-77. 10. Grimes DA, Mishell D R Jr and David H P, 1992. A randomized clinical trial of mifepristone (RU4861 for induction of delayed menses: efficacy and acceptability Contraception. 46:1-10. 11. UK Multicentre Trial, 1990. The efficacy and tolerance of 6
mifepristone and prostaglandin in first trimester termination of pregnancy. British Journal of Obstetrics & Gynaecology. 97480-86. 12. Baird D T. Personal communication. 13. Rimmer C, Horga M, Alder E M et al, 1992. Do women want a once-a-month pill? Human Reproduction. 7:608-11. 14. Glasier A, Thong K J, Dewar M et al, 1992. Randomised trial of mifepristone (RU486) and high dose estrogen-progestogen as an emergency contraceptive. New England Journal of Medicine. 327:1041-44. 15. Webb A M C, Russel J and Elstein M, 1992. Comparison of the Yuzpe reglme, danazol and mifepristone in oral post-coital contraception. British Medical Journal. 305:927-31. 16. Klitsch M, 1989. RU486: 7’he Science and the Politics. Alan Guttmacher Institute, New York. 17.Arilha M and Barbosa R M, 1993. Cytotec in Brazil: ‘At least it doesn’t kill’. Reproductive Health Matters. Z(November):41-52.
Reproductive
lfealth
Matters,
No 6, November
1995
RBSUMB
RESUMEN
La mise au point d’une methode medicale pour declencher l’avortement - l’association de mifepristone (ou RU486) et de prostaglandine permet desormais aux femmes de choisir la facon dont elles preferent mettre fin a leur grossesse, dans les pays ou les deux produits sont autorises, et ou on peut avoir acces a des techniques medicales. La liberte de choisir la methode d’interruption de grossesse peut alleger quelque peu l’angoisse des avortees. L’article fait une revue des etudes actuelles et se demande pourquoi des femmes choisissent une methode plutot qu’une autre. 11discute les potentialites de la mifepristone a des fins contraceptives, pour la contraception d’urgence et dans d’autres La pression des indications eventuelles. adversaires de l’avortement peut empecher de developper ou de faire homologuer diverses utilisations therapeutiques de la mifepristone, meme la ou ce produit semble devoir Ctre le traitement de choix, par exemple pour la contraception d’urgence. 11 faut ou bien l’accepter, ou trouver des moyens de vaincre les repugnances a son homologation pour toutes les averees qu’il peut avoir, a indications commencer par l’avortement precoce.
Desde la invention de un metodo medico para inducir el abort0 (el mifepristone, conocido inicialmente corn0 RU486, mas la prostaglandina) la mujer tiene la posibilidad de elegir coma prefiere interrumpir su embarazo en aquellos ambas sustancias paises en que estan autorizadas, y en contextos en 10s que existe acceso a tecnicas medicas. La libertad de poder elegir el metodo de abort0 puede contribuir a aliviar en parte su ansiedad. Este ensayo hate una revision de 10s estudios existentes y examina por que las mujeres escogen uno u otro metodo. Discute tambien el potential de1 mifepristone para uso anticonceptivo, coma anticonceptivo de emergencia y otras posibles indicaciones. La presion en contra de1 abort0 puede impedir el desarrollo o autorizacidn de toda una variedad de uses terapeuticos de1 mifepristone, incluso en cases en 10s que seria el tratamiento preferido, coma parece suceder en el case de su utilization coma metodo anticonceptivo de emergencia. 0 bien aceptamos esto o debemos encontrar la forma de superar la reticencia a autorizar esta sustancia para todas la indicaciones demostradas que pueda tener, comenzando por el abort0 temprano.
HE acceptability of medical abortion using mifepristone has been assessed in a number of cultural settings - Scotland,1,2,3 England,4 Sweden,5 France,” Denrnark,7 Hong Kong,*tg and the USA.l” The studies differ quite significantly, however, and are difficult to compare. Most were undertaken when RU486 was new and at a time when RU486 was unlicensed in the particular country where the study was done. Many women are understandably hesitant to opt for a new and relatively untested treatment in whatever field of medicine, and this almost certainly affects not only which method they choose but also colours their experience of it. Many of the studies were undertaken as part of a trial of the efficacy of the method. In the Oxford study,4 for example, women were invited either to participate in the study or to undergo routine surgical abortion. They were not simply choosing between two methods, but also whether to participate in a trial or not. Where an acceptability study is tacked on to an efficacy study, the demands of the study itself undoubtedly influence the woman’s choice of method too. In Tang’s pilot study,8 for example, women choosing medical abortion had to attend the study site on seven separate occasions while those choosing surgical abortion had to attend Only twice.
T
Comparability of the studies is also complicated by significant differences in the details of the abortion method. Surgical abortion may be done under local or general anaesthetic, while medical abortion may involve the use of prostaglandins administered vaginally rather than intramuscularly. One of the studies7 used mifepristone alone. The duration of hospital stay also varied considerably. In one Scottish study,* the women were asked to stay in hospital for only four hours on the day of prostaglandin administration, compared with six hours in Hong Kong.* Again, in the Hong Kong centre8 surgical abortion involved an overnight stay in hospital which was not required in Scotland.3 Despite these major differences there are nevertheless enough similarities to allow some general comments about the acceptability of medical abortion with RU486. Most studies determined the reasons why women chose either medical or surgical abortion, whether women who chose one or other method had certain characteristics in common, and tried to make some standard assessment of acceptability by would which method a woman asking recommend to a friend or opt for in the future should the need arise. Perhaps the commonest reason why women
I 147 I
have chosen medical abortion as opposed to vacuum aspiration is the perception that the former is a more ‘natural’ procedure, which avoids exposure to general anaesthesia. In Hong Kong8 some women felt less guilty about having an abortion because the medical method seemed more like a natural miscarriage. The fear of general anaesthesia is obviously not an issue if surgical abortion is performed under local anaesthesia. In the French study’s only nine per cent of women chose vacuum aspiration under general anaesthesia while 27 per cent chose vacuum aspiration under local anaesthesia. Even when local anaesthesia was available, however, the great majority of women (62 per cent) opted for medical abortion. A minority of women, on the other hand, chose surgical abortion in the Hong Kong studf because they wanted to be unconscious and unaware of events. For some women the anxiety associated with ‘seeing the baby’ prompted a choice of general anaesthesia. In fact, this is not the case during first trimester medical abortion, when only blood and tissue are visible, so this fear is unfounded, a point which can be made during counselling. In most studies, some women’s choice of method has depended on their perception of its safety. Perceptions have varied considerably, with some women concerned about the safety of the drugs used for medical abortion and others concerned about the use of instruments for surgical abortion. As medical abortion becomes more widespread, the fear of the drugs will most likely decrease for many women. Medical abortion currently requires more visits to the hospital or clinic and a 48-hour wait between the two parts of the procedure. Many women have chosen surgical abortion because it appears to be quicker and to demand less time off work, unless an overnight stay is required, which is still the case in some countries. Moreover, the 48-hour wait inherent in medical abortion is a time of anxiety which some women feel unable to cope with. For some women the fear of side effects has deterred them from choosing medical abortion. In the multicentre study undertaken in the United Kingdom, l1 21 per cent of women complained of severe pain in the two days following prostaglandin administration and around 30 per cent of all participants required non-narcotic analgesia.
In addition, between 13 and 37 per cent needed narcotic analgesia, but this depended both on parity and also highly significantly on the centre where the abortion took place. Twenty-five per cent of the women vomited and 13 per cent experienced diarrhoea after prostaglandins were given. Thong and colleagues’ working in Edinburgh found that the need for analgesia was related to length of gestation, parity and a history of dysmenorrhoea - all factors which can be determined during the time of counselling a woman about her choice of method. Medical abortion is thought to involve more blood loss post-operatively and a longer duration of bleeding than with surgical abortion. In fact, the total blood loss is not greater. However, with a surgical procedure much of the bleeding occurs acutely at the time of operation and is unnoticed by the woman. In most studies, medical abortion seemed more likely to be chosen by women who were younger, single, better educated and of a higher socio-economic status. In an as yet unpublished audit from EdinburghI women who smoked were more likely to choose surgical abortion. In all the published studies, the vast majority of women were happy with whichever method they had chosen, said they would choose the same procedure again if the need for abortion arose, and would recommend it to a friend. It is difficult for a woman to choose between two methods unless she has experienced both and is faced with a choice on a third occasion. Even then, the circumstances surrounding the unplanned pregnancy and the professional staff involved with counselling and carrying out the abortion will almost certainly be different, and both will have a major influence on a woman’s feelings about the procedure. Perhaps the most helpful study of acceptability comes from Aberdeen3 in which the 54 per cent of women who felt unable to choose between the two procedures were randomised. As with other studies, around 90 per cent of the women who made a choice were happy with the outcome, but there were significant differences in the extent of dissatisfaction among those who were randomised. Only two per cent of randomised women were unhappy with surgical abortion, but 22 per cent were unhappy with the medical method. In contrast, in another study
Reproductive
from Aberdeen,l ten out of 13 women who had experienced both surgical and medical abortion said that they preferred medical abortion. This study is the only one which reported psychiatric morbidity associated with abortion, but it found no difference between medical and surgical methods. Given the choice between surgical and medical methods of inducing abortion, many women seem to prefer the medical approach. Whatever method they choose, a small minority of women find the experience unsatisfactory and it is possible that this is more likely when medical abortion is chosen. When any new therapy is introduced - particularly with the amount of publicity that surrounded RU486 abortion expectations may be unrealistically high. The provision of accurate and detailed information about all abortion procedures should overcome this problem. Indeed, the very fact that women themselves have a say in how the abortion is performed probably increases the acceptability of the method they choose.
OTHER USESOFMIFEPRISTONE RU486 has great potential for
use as a contraceptive method and a number of approaches - very low dose daily administration, once-a-week pills, once-a-month pills, and emergency post-coital contraception - are all being investigated. To date, researchers have concentrated on the efficacy of these methods rather than acceptability. Protocols for the development of new contraceptive techniques are complicated and entail a multitude of frequent and often invasive investigations, such as blood tests, cervical smears and endometrial biopsies, which are not necessary when the method becomes available for routine use. Moreover, phase 1 studies are often undertaken on women who are not at risk of pregnancy, women who are sterilised or using a barrier method of contraception, so true acceptability is almost impossible to measure. We undertook a surveyla of women in Scotland, Slovenia and Romania to determine the theoretical acceptability of a once-a-month pill. The once-a-month concept was acceptable, but in Scotland, and to a lesser extent in Slovenia, the acceptability depended on the mode of action. Only 24 per cent of the women in
Health Matters, No 6,
November
1995
Edinburgh were prepared to use a pill which acted after implantation had occurred and only 33 per cent in Slovenia. In two studies of 600 mg RU486 as an emergency post-coital contraceptive14,15 the incidence of side effects was highly significantly less in women who took RU486 in comparison with those given the standard combined oestrogen-progestogen (Yuzpe) regimen. Moreover, the Yuzpe regimen requires the ingestion of two doses of pills separated by 12 hours, while RU486 needs to be taken only once. Although this was not specifically measured, it is likely that the single dose and reduced side effects with RU486 given in this manner would make it more acceptable than the Yuzpe regimen. RU486 has great potential for development as a contraceptive and indeed, for other uses such as the treatment of breast cancer. Yet the use of RU486 and any other anti-progestin that may be developed will be limited if it is only thought of as an ‘abortion pill’. Thus, the introduction of an anti-progestin, for whatever other therapeutic use, into a country where abortion is illegal or where RU486 has not been licensed as an abortifacient may be extremely difficult. Even in countries where RU486 is licensed for the induction of early abortion, it is currently subject to more controls than perhaps any other drug. In the United Kingdom, for example, both the drug licensing authority and the manufacturers are responsible for a set of stringent restrictions on its provision. In some countries, such as the USA, drug regulatory authorities have a legal mandate to consider a product application only for the therapeutic purposes for which approval is sought. Nevertheless, ideological pressure, which may even come from the government itself, may be hard to resist. A review of the science and politics of RU486 in 1989 in the USA says: ‘. . As long as the deadlock on RU486 continues, its other potential lifesaving applications will remain unexplored.‘16 This review points out the fear that the licensing of the drug for one purpose would inevitably lead to it ultimately being used for abortion as well. This would almost certainly be the case in other countries. In the United
Glasier
Kingdom, once a drug becomes available a is free to use it as he or she sees fit. If the use accords with accepted clinical practice, legal redress is unlikely. Thus, many doctors prescribe oral contraceptive pills containing 50 mcg oestrogen for emergency contraception, even though the pills are not licensed for this purpose. Because the practice is so widespread and clinically sound, it is acceptable medico-legally. In this way, if RU486 were licensed for the treatment of breast cancer in a country where it was not licensed for abortion, a doctor could successfully argue for the validity of its use as an abortifacient, demonstrated in evidence from other countries. Even if doctors themselves refrained from providing RU486 for the unlicensed purpose of abortion, once it was available for other purposes and if it were available over the counter, there would be potential for its use doctor
directly by women as an abortifacient, as has happened with the anti-ulcer drug misoprostol (a prostaglandin) in Brazil and elsewhere, for inducing abortion illegally.17 If contraceptives containing an anti-progestin could only be administered in a controlled in the way that mifepristone is manner, administered today for early abortion, then it would not be possible to develop anti-progestins for contraception. Hence, either we have to accept that anti-abortion pressure may prevent the development or licensing of a range of therapeutic uses for mifepristone, even where it would be the preferred treatment, as seems to be the case with its use for emergency contraception, or we have to find a way to overcome the reluctance to license mifepristone for all of the scientifically proven indications it may have, starting with early abortion.
References 1. Urquhart D R and Templeton A A, 1991. Psychiatric morbidity and acceptability following medical and surgical methods of induced abortion. British Journal of Obstetrics and Gynaecology. 98:396-99. 2. Thong K J, Dewar M H and Baird D T, 1992. What do women want during medical abortion? Contraception. 46:435-42. 3. Henshaw R C, Naji S A, Russell I T et al, 1993. Comparison of medical abortion with surgical vacuum aspiration: women’s preferences and acceptability of treatment. British Medical Journal. 307:714-17. 4. Hill N C W, Ferguson J and Mackenzie I Z, 1990. The efficacy of oral mifepristone (RU38486) with aprostaglandin El analog vaginal pessary for the termination of early pregnancy : complications and patient acceptability. American Journal of Obstetrics and Gynecology. 162:414-17. 5. Holmgren K, 1992. Women’s evaluation of three early abortion methods. Acta Obstetrica Gynecologica
Scandinavia. 71:611-23. Bachelot A, Cludy Land Spira A, 1992. Conditions for choosing between drug-induced and surgical abortions. Contraception. 45:547-59. 7. Legarth J, Peen U B and Michelson J W, 1991. Mifepristone or vacuum aspiration in termination of early pregnancy. European Journal of Obstetrics, Gynecology and Reproductive Biology. 41:91-96. 8. Tang G W K, 1991. A pilot study of acceptability of RU486 and ON0802 in a Chinese population. Contraception. 44:523-32. 9 Tang G W K, Lau 0 W K and Yip P, 1993. Further acceptability evaluation of RU486 and ON0 802 as abortifacient agents in a Chinese population. Contraception. 48267-77. 10. Grimes DA, Mishell D R Jr and David H P, 1992. A randomized clinical trial of mifepristone (RU4861 for induction of delayed menses: efficacy and acceptability Contraception. 46:1-10. 11. UK Multicentre Trial, 1990. The efficacy and tolerance of 6
mifepristone and prostaglandin in first trimester termination of pregnancy. British Journal of Obstetrics & Gynaecology. 97480-86. 12. Baird D T. Personal communication. 13. Rimmer C, Horga M, Alder E M et al, 1992. Do women want a once-a-month pill? Human Reproduction. 7:608-11. 14. Glasier A, Thong K J, Dewar M et al, 1992. Randomised trial of mifepristone (RU486) and high dose estrogen-progestogen as an emergency contraceptive. New England Journal of Medicine. 327:1041-44. 15. Webb A M C, Russel J and Elstein M, 1992. Comparison of the Yuzpe reglme, danazol and mifepristone in oral post-coital contraception. British Medical Journal. 305:927-31. 16. Klitsch M, 1989. RU486: 7’he Science and the Politics. Alan Guttmacher Institute, New York. 17.Arilha M and Barbosa R M, 1993. Cytotec in Brazil: ‘At least it doesn’t kill’. Reproductive Health Matters. Z(November):41-52.
Reproductive
lfealth
Matters,
No 6, November
1995
RBSUMB
RESUMEN
La mise au point d’une methode medicale pour declencher l’avortement - l’association de mifepristone (ou RU486) et de prostaglandine permet desormais aux femmes de choisir la facon dont elles preferent mettre fin a leur grossesse, dans les pays ou les deux produits sont autorises, et ou on peut avoir acces a des techniques medicales. La liberte de choisir la methode d’interruption de grossesse peut alleger quelque peu l’angoisse des avortees. L’article fait une revue des etudes actuelles et se demande pourquoi des femmes choisissent une methode plutot qu’une autre. 11discute les potentialites de la mifepristone a des fins contraceptives, pour la contraception d’urgence et dans d’autres La pression des indications eventuelles. adversaires de l’avortement peut empecher de developper ou de faire homologuer diverses utilisations therapeutiques de la mifepristone, meme la ou ce produit semble devoir Ctre le traitement de choix, par exemple pour la contraception d’urgence. 11 faut ou bien l’accepter, ou trouver des moyens de vaincre les repugnances a son homologation pour toutes les averees qu’il peut avoir, a indications commencer par l’avortement precoce.
Desde la invention de un metodo medico para inducir el abort0 (el mifepristone, conocido inicialmente corn0 RU486, mas la prostaglandina) la mujer tiene la posibilidad de elegir coma prefiere interrumpir su embarazo en aquellos ambas sustancias paises en que estan autorizadas, y en contextos en 10s que existe acceso a tecnicas medicas. La libertad de poder elegir el metodo de abort0 puede contribuir a aliviar en parte su ansiedad. Este ensayo hate una revision de 10s estudios existentes y examina por que las mujeres escogen uno u otro metodo. Discute tambien el potential de1 mifepristone para uso anticonceptivo, coma anticonceptivo de emergencia y otras posibles indicaciones. La presion en contra de1 abort0 puede impedir el desarrollo o autorizacidn de toda una variedad de uses terapeuticos de1 mifepristone, incluso en cases en 10s que seria el tratamiento preferido, coma parece suceder en el case de su utilization coma metodo anticonceptivo de emergencia. 0 bien aceptamos esto o debemos encontrar la forma de superar la reticencia a autorizar esta sustancia para todas la indicaciones demostradas que pueda tener, comenzando por el abort0 temprano.